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The study aims to test the diagnostic accuracy of T1 mapping for the diagnosis of cardiac amyloidosis prospectively. The hypothesis is that T1 mapping in older patients with symptomatic heart failure, increased LV wall thickness and elevated cardiac biomarkers is non-inferior to the reference method to diagnose cardiac amyloidosis (CA).
As secondary measure, a web-based ATTR probability estimator for the diagnosis of CA will be evaluated.
Cardiac amyloidosis (CA) is an important differential diagnosis in older patients with symptomatic heart failure with preserved or mid-range ejection fraction and increased left ventricular wall thickness. The prevalence of CA among patients with heart failure and left ventricular (LV) hypertrophy is approximately 13%. However, diagnosis of CA is challenging because specific clinical signs are often lacking.
Amyloid fibrils deposit in the extracellular space of the myocardium increases myocardial T1 values on cardiac magnetic resonance (CMR). Therefore, T1 imaging provides a promising non-invasive method to identify CA.
A preliminary retrospective analysis of 128 patients with increased LV wall thickness identified an area under the curve of 0.9954 (p<0.0001) for native T1 to detect CA. The optimal cut-off value was 1341ms, with a sensitivity of 100% and a specificity of 97%.
The investigators aim to test the diagnostic accuracy of T1 mapping for the diagnosis of CA compared to the reference method prospectively. Moreover, the web-based ATTR probability estimator for the diagnosis of CA will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CMR T1 mapping | Diagnostic accuracy of T1 mapping and ATTR probability estimator are tested against the reference methods (99mTc-DPD scintigraphy, laboratory screening for multiple myeloma / AL amyloidosis; or cardiac biopsy, if noninvasive evaluation is inconclusive) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Native T1 CMR | Diagnostic Test | Observed method |
| |
| Web-based ATTR probability estimator (Pfizer, New York) |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of T1 mapping for diagnosis of CA | Comparison of CMR T1 mapping to the reference method for diagnosis of CA | up to 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of ATTR probability estimator to predict CA | Comparison of a probability score to predict ATTR with the final diagnosis of ATTR | up to 7 days |
| Association of parametric T1 values with cardiovascular outcome |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with symptomatic heart failure (NYHA functional class II to IV, LVEF ≥40%), increased left ventricular wall thickness and elevated cardiac biomarkers
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Leipzig | Leipzig | Saxony | 04103 | Germany |
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| Diagnostic Test |
Observed method |
|
| 99mTc-DPD scintigraphy | Diagnostic Test | Reference method |
|
| Laboratory screening for multiple myeloma / AL amyloidosis | Diagnostic Test | Reference method |
|
| Cardiac biopsy | Procedure | If non-invasive tests for CA (99mTc-DPD scintigraphy, biochemistry) are inconclusive |
|
All-cause death, cardiovascular death and heart failure hospitalizations
| 1 year |
| Association of ATTR probability estimator values with cardiovascular outcome | All-cause death, cardiovascular death and heart failure hospitalizations | 1 year |
| ID | Term |
|---|---|
| D017379 | Hypertrophy, Left Ventricular |
| D028227 | Amyloid Neuropathies, Familial |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D009422 | Nervous System Diseases |
| D017772 | Amyloid Neuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D028226 | Amyloidosis, Familial |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D000686 | Amyloidosis |
| D057165 | Proteostasis Deficiencies |
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